EDUCATION LEVEL

• Bachelors Degree

EXPERIENCE

• Minimum 3 years

EXPERIENCE DETAILS

• 3 years in clinical operations or healthcare related field.
• Education and work experience in project management, life sciences and/or technical field.
• Knowledge of data collection best practices for clinical trials.
• Knowledge of global clinical operations.
• Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.
• Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.
• Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.
• Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.
• Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.
• Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.

MAIN PURPOSE OF ROLE

• The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.
• As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager’s therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.

MAIN RESPONSIBILITIES

• Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.
• Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
• Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.
• Conduct Central Monitoring activities, as described in Central Monitoring Plan.
• Direct all data cleaning activity related to assigned studies.